Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-7782 injection, which will soon commence clinical trials [1] Group 1: Product Development - SHR-7782 injection is a self-developed therapeutic biological product that specifically binds to tumor cell surface antigens to kill tumor cells, intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-7782 injection project has reached approximately 48.2 million yuan [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-7782 injection, which is designed for the treatment of advanced solid tumors [1] Group 1 - The SHR-7782 injection is a self-developed biopharmaceutical product that specifically binds to tumor cell surface antigens [1] - The clinical trial for SHR-7782 injection will commence shortly [1] - The product aims to kill tumor cells and is intended for use in treating advanced solid tumors [1]

Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-7782 injection, which will commence shortly [1] Group 1: Product Development - SHR-7782 injection is a self-developed therapeutic biological product that specifically binds to tumor cell surface antigens to kill tumor cells, intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - The total research and development investment for the SHR-7782 injection project has reached approximately 48.2 million yuan [1]

| 2025-08-14 | 恒瑞医药 | 600276 | 62.82 | 565.38 | 国泰海通证券股份 有限公司总部 | 华泰证券股份有限 公司北京雍和宫证 | | --- | --- | --- | --- | --- | --- | --- | | 交易日期 | 证券简称 | 证券代码 | 成交价(元) 成交金额(万元) 成交量( * ) 买入营业部 | | | 卖出营业部 | 8月14日，恒瑞医药大宗交易成交9万股，成交额565.38万元，占当日总成交额的0.16%，成交价62.82元，较市场收盘价62.82元持平。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-116 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物医药有限公司收到国家药品监督管理局（以下简称"国家药监局"）核准签 发关于 SHR-7782 注射液的《药物临床试验批准通知书》，将于近期开展临床试 验。现将相关情况公告如下： 一、药物的基本情况 药物名称：SHR-7782 注射液 剂 型：注射剂 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 5 月 23 日受理的 SHR-7782 注射液临床试验申请符合药品注册的有关要求，同 意本品在晚期实体瘤中开展临床试验。 二、药物的其他情况 SHR-7782 注射液是公司自主研发的一款治疗用生物制品，可特异性结合肿 瘤细胞表面抗原，杀伤肿瘤细胞，拟用于治疗晚期实体瘤。经查询，目前国内外 尚无同类药物获批上市。截至目前，SHR-7782 注射液相关项 ...

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SHR-7782 injection, a novel biopharmaceutical for treating advanced solid tumors [1] Group 1 - SHR-7782 injection is a self-developed therapeutic biopharmaceutical that specifically binds to tumor cell surface antigens to kill tumor cells [1] - The drug is intended for the treatment of advanced solid tumors [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of SHR-7782 injection, a novel biopharmaceutical aimed at treating advanced solid tumors [1] Company Summary - SHR-7782 injection is a self-developed therapeutic biopharmaceutical that specifically binds to tumor cell surface antigens to kill tumor cells [1] - The clinical trial is set to commence shortly, indicating progress in the company's research and development efforts [1] - The total R&D investment for the SHR-7782 injection project has reached approximately 48.2 million yuan [1] Industry Summary - Currently, there are no similar drugs approved for market use domestically or internationally, highlighting a potential competitive advantage for the company [1]

Core Insights - The Shanghai 50 Index has seen a strong increase of 1.53%, with notable gains from constituent stocks such as Cambricon Technologies, which rose by 14.05% [3] - The Shanghai 50 ETF (510050) has also experienced a rise of 1.36%, marking its fourth consecutive increase [3] - The latest scale of the Shanghai 50 ETF reached 171.475 billion yuan, a six-month high, with a recent increase of 8.51 million shares in the past week, accumulating over 2.1 billion yuan in inflows over the last five trading days [3] Scale and Fees - The management fee for the Shanghai 50 ETF is 0.15%, and the custody fee is 0.05%, making it the lowest among comparable funds [3] - The top ten weighted stocks in the Shanghai 50 ETF account for a total of 49.36% as of July 31, 2025, including major companies like Kweichow Moutai, China Ping An, and China Merchants Bank [3] Stock Performance - The performance of key stocks within the Shanghai 50 ETF includes: - Kweichow Moutai: up 1.06%, weight 10.49% - China Ping An: up 3.22%, weight 7.07% - China Merchants Bank: up 0.87%, weight 6.74% - Industrial Bank: up 0.04%, weight 4.60% - Yangtze Power: up 0.69%, weight 4.37% - CITIC Securities: up 1.59%, weight 3.19% - Industrial and Commercial Bank of China: up 0.65%, weight 3.15% - Hengrui Medicine: up 1.37%, weight 2.75% [5]

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **healthcare industry in China**, particularly the pharmaceutical and biotech sectors, highlighting recent license-out events and deals in the first half of 2025. Company-Specific Insights Hengrui Medicine - **License Agreement with GSK**: On July 28, 2025, Hengrui licensed out global rights (excluding Greater China) for HRS-9821 and up to 11 other products to GSK for an upfront payment of **US$500 million** and potential milestone payments totaling **US$12 billion** [1][8][19]. - **Clinical Stage**: HRS-9821 is a PDE3/4 inhibitor currently in Phase-I clinical trials, aimed at treating COPD as an auxiliary maintenance treatment [1]. - **Financial Impact**: The upfront payment is included in the DCF model, resulting in a **51.3% increase** in the 2025 EPS forecast [2][7]. The updated price objective for Hengrui is raised to **RMB56.8** from **RMB51.5** [2]. - **Market Capitalization Comparison**: Hengrui's market cap is approximately **74%** of GSK's, while its revenue is only about **10%** of GSK's projected revenue for 2024, indicating a potential **10+ years** for Hengrui to reach GSK's revenue level assuming a **20% CAGR** [2]. 3SBio - **License Agreement with Pfizer**: On July 24, 2025, 3SBio announced a license agreement with Pfizer for the development and commercialization of SSGJ-707 in mainland China, with a non-refundable option fee of up to **US$150 million** [3]. Industry Trends - **License-Out Deals Growth**: In the first half of 2025, the total value of license-out deals by Chinese firms reached **US$60 billion**, a **135% year-over-year growth**, surpassing the total for the entire year of 2024 [4][12]. - **Upfront Payments**: Upfront payments for Chinese firms grew **196% year-over-year** to **US$2.6 billion** in 1H25, with the number of deals increasing by **71.4%** to **72** [4][13][15]. - **R&D Capability**: The surge in deals indicates that Chinese pharma/biotech firms possess world-leading R&D capabilities, leading to significant financial rewards through licensing [4]. Financial Metrics - **Hengrui's Financial Estimates**: - Total Revenue for 2025 is estimated at **RMB33.266 billion**, a **12.1% increase** from previous estimates [7]. - Net Income is projected at **RMB9.305 billion**, reflecting a **51.3% increase** [7]. - Basic EPS is expected to be **RMB1.47**, up from **RMB0.97**, marking a **51.3% increase** [7]. Risks and Considerations - **Downside Risks for Hengrui**: Include setbacks in drug development, slow sales ramp-up of new products, increasing pricing pressures, and competition in the PD-1 market [22]. - **Upside Risks**: Higher-than-expected net profit margins and faster progress of pipeline candidates could positively impact the price objective [22]. Conclusion - The healthcare sector in China, particularly the pharmaceutical industry, is experiencing significant growth in licensing activities, with Hengrui Medicine and 3SBio leading notable deals. The financial outlook for Hengrui has improved significantly due to recent agreements, although risks remain that could impact future performance.

Core Viewpoint - The article highlights the rapid growth and transformation of China's innovative drug development sector, emphasizing its shift from quantity to quality and its increasing global competitiveness [2][8][20]. Summary by Sections Innovative Drug Approvals - In the first half of 2025, China approved 43 innovative drugs, a 59% increase year-on-year, nearing the total of 48 approvals in 2024 [2]. - The innovative drug sector is benefiting from favorable policies that support the entire industry chain, showcasing China's growing global competitiveness in biopharmaceuticals [2]. Clinical Development and Regulatory Efficiency - The average time for innovative drug approval has decreased from 420 working days in 2017 to 235 days [5]. - Measures have been implemented to improve access to rare disease medications, with several rare disease drugs approved in the first half of 2025 [5][7]. Shift in Drug Development Focus - Chinese innovative drug development is transitioning from "Me-too" drugs to "Best-in-class" drugs, with a focus on unmet clinical needs [8]. - The industry is enhancing its research capabilities and internationalization, with a notable increase in original innovations [8][20]. International Collaboration and Market Expansion - Chinese companies are exploring various models for international recognition, including licensing, joint development, and independent market entry [10][12]. - Notable collaborations include agreements between companies like 3SBio and Pfizer, and Heng Rui Pharma with GSK, aimed at accelerating drug development and market entry [11][12]. Global Registration and Recognition - Chinese innovative drugs are achieving global recognition, with products like Zepzelca and others gaining approval in major markets [16]. - Companies are focusing on high-quality clinical research and compliance with international standards to enhance their global competitiveness [18][19]. Challenges and Future Directions - Despite progress, challenges remain in areas such as platform technology accumulation and global commercialization experience [23]. - The industry needs to enhance its capabilities in original innovation and market access strategies to improve the commercialization of new drugs [23][24]. Policy Support and Industry Development - The government is actively supporting true innovation and differentiated innovation through various policies [21][24]. - Future industry development requires collaboration across multiple sectors, including regulatory improvements and talent development [24][25].